Ukraine: Domestic Equipment Could Distort AIDS Blood Test Results

Kyiv, 1 March 1999 (RFE/RL) -- Ukrainian officials are disputing claims that they are hastening the spread of AIDS by requiring the use of domestically produced equipment that does not reliably screen blood used in transfusions.

The claim has been made by Valery Ivasyuk, former head of the National Committee for the Prevention of AIDS and Drug Abuse.

A government decree signed in January of last year forbids the Health Ministry from buying imported testing equipment "where appropriate quantities of Ukrainian-produced equivalents are available." The decree effectively bans imported test systems from the Ukrainian market and grants a monopoly to Diaprof-Med, the only Ukrainian firm producing a test system.

Ivasyuk says that the Diaprof-Med test system gives false or ambiguous results in 60 percent of cases.

Ivasyuk was dismissed from his post at the AIDS prevention committee in January of last year and the entire committee was dissolved last May as part of a government economy drive. His critics have charged that Ivasyuk's accusations are politically motivated.

Ivasyuk supports his claims with data from health authorities. A state commission that tested the accuracy of blood-screening equipment until last October found that during the first 10 months of last year, more than 1,500 samples of screened blood were found on additional testing to be infected with HIV, the virus that causes AIDS. In 1996, before the law calling for the use of Ukrainian-made testing equipment, there were only 400 registered cases where blood was tested again and found to be HIV-positive.

Ivasyuk says: "If earlier there were only indications that the Ukrainian blood donor service was a factor in the rise of AIDS, now we have data of hundreds of cases where donors have given infected blood. And we have information of the fact when HIV infected blood has been given to patients."

Sergei Berezhnov, head of the epidemiological department within the Ministry of Health, confirms that there are several cases under investigation where patients may have been infected with the HIV virus via a blood transfusion. In one proven case in the Kirovograd region last year, a man was given a transfusion of unscreened blood and contracted the infection.

The most recent case is in the Chernigiv region, where a patient is suspected of contracting HIV through blood donated by a woman with HIV. Ivasyuk alleges that the blood was tested several times and cleared by the Diaprof-Med system before a further test on American and French systems indicated the donor had had the virus for over six months. But the head of the Chernigiv medical facility which collected the blood, Vasily Zub, denies the charge, saying it "didn't approve this blood". Zub added that in his clinic, "the Diaprof-Med system works very well."

The Health Ministry's Berezhnov acknowledges that there have been cases where the test has given false or ambiguous results, but insists that the test itself was not at fault.

"Each case was investigated by a special commission, which found that it was not a question of the test itself and its quality, but a question of how it was used.... [the system] satisfies monitoring requirements 100 percent."
Berezhnov said there was no difference in the percentage of accuracy between Diaprof-Med's system and foreign systems. He added that there was no cause for concern over Diaprof-Med because the central reference laboratory in Kyiv tests doubtful blood samples with the French and American systems. Berezhnov said that the government has insisted on purchasing only the Diaprof-Med system because the country cannot afford to import equipment.

Lydia Andruschak, national coordinator for UNAIDS in Ukraine, was reluctant to comment on Ivasyuk's charges, saying that her United Nations organization only had data from news reports.

But she told RFE/RL "Ivasyuk formerly had charge of the commission that tested the accuracy of screening, so he has grounds to speak," adding, "We don't have such grounds."

Andruschak said it was a matter of concern that the Ukrainian market was entirely dominated by Diaprof-Med, compared to Russia where there are 13 domestically-produced test systems on the market. She said the lack of competition might lead to low standards.

UNAIDS estimates that Ukraine has the fastest-growing HIV infection rate in all Europe, jumping from 183 registered HIV cases in 1994 to nearly 40,000 this month, according to the Health Ministry figures. Seven hundred people have developed full-blown AIDS.

Andruschak, Ivasyuk and Berezhnov all agree that the donor system in Ukraine needs urgent reform. At present it often attracts the homeless, alcoholics or drug users, because each donation is paid.

According to Berezhnov, blood from 800 donors last year was rejected for transfusion because the blood samples turned out to be HIV positive, and he suggested that many more donors may be getting through the preliminary screening system. Berezhnov says: "This is the question for today....to organize selection of donors and make giving blood voluntary."